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目的:对两种国产皮下埋植避孕剂的长期应用效果及副反应进行评价。方法:采用前瞻性临床多中心对比研究,共在5省58个分中心进行了7941例长达5年的临床应用和随访研究。结果:两种埋植剂5年的净累积妊娠率仅为0.257/百妇女(Ⅰ型)和1.569/百妇女(Ⅱ型),两者间有极显著差异;5年累积续用率高达76.23/百妇女(Ⅰ型)和77.98/百妇女(Ⅱ型);主诉副反应的发生率开始较高,随应用时间延长而逐年降低,由开始的近50％降至第5年时的15％左右,最主要的副反应是月经异常,占终止人数的74.8％,月经副反应发生率和因月经异常的停用率Ⅰ型埋植剂明显高于Ⅱ型。结论:两种国产皮下埋植避孕剂均是高效、长效、可接受性较好的新型避孕药。
Objective: To evaluate the long-term effects and side effects of two kinds of domestic contraceptives implanted subcutaneously. Methods: A prospective clinical multicenter comparison study was conducted in 7941 patients up to 5 years in 58 centers in 5 provinces. Results: The net cumulative pregnancy rates of the two implants for 5 years were only 0.257 / 100 women (Ⅰ type) and 1.569 / 100 women (Ⅱ type), with significant differences between the two implants. The 5-year cumulative follow-up rate was as high as 76.23 Per 100 women (type I) and 77.98 per hundred women (type II). The incidence of chief complaint side effects started to increase and decreased year by year with the increase of application time, from nearly 50% at the beginning to 15% at the fifth year , The main side effects are menstrual abnormalities, accounting for 74.8% of the termination number. The incidence of menstrual side effects and discontinuation rate of menstrual abnormalities type Ⅰ implants were significantly higher than those of type Ⅱ. CONCLUSION: Two kinds of domestic contraceptives implanted under the skin are both new and effective contraceptives.